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Detection of Pathological Lymphocytes in Patients With Autoimmune Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02813083
Recruitment Status : Enrolling by invitation
First Posted : June 24, 2016
Last Update Posted : December 11, 2019
Information provided by (Responsible Party):
University of Minnesota

Brief Summary:
This study will help the investigators design a method to detect the disease-causing immune cells in patients with rheumatoid arthritis (RA). Such methods are not currently available, but if successful, would help scientists to better understand the causes of RA.

Condition or disease Intervention/treatment
Arthritis, Rheumatoid Other: No intervention (observational)

Detailed Description:

The investigators are interested in learning about the immune cells in the blood that contribute to disease in patients with rheumatoid arthritis (RA). They have developed a method for identifying a specific type of immune cells that can react against normal tissues in the body.

In this study, the investigators will enroll RA patients from the University of Minnesota clinics, collect blood samples from enrolled patients, and process the blood samples to isolate DNA, RNA, serum, and blood cells. They will use the serum to detect whether specific autoantibodies (Anti-cyclic Citrullinated Peptide, or anti-CCP) are present. In cases where anti-CCP antibodies are detected, the investigators may quantify the numbers of immune cells present that contain receptors with the same anti-CCP specificity. They may also test whether the numbers of immune cells with these receptors correlate with measures of disease activity in RA patients.

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 155 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 5 Years
Official Title: Detection of Pathological Lymphocytes in Patients With Autoimmune Disease
Study Start Date : August 2011
Estimated Primary Completion Date : September 2023
Estimated Study Completion Date : September 2024

Resource links provided by the National Library of Medicine

Group/Cohort Intervention/treatment
Rheumatoid Arthritis
Rheumatoid arthritis patients
Other: No intervention (observational)
No intervention (observational)

Primary Outcome Measures :
  1. DAS28-ESR [ Time Frame: 6 months ]

Biospecimen Retention:   Samples With DNA
Serum, peripheral blood mononuclear cells

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
The investigators will enroll 155 rheumatoid arthritis patients from the University of Minnesota Rheumatology clinics.

Inclusion Criteria:

  • Diagnosis of rheumatoid arthritis

Exclusion Criteria:

  • Use of rituximab immediately prior to visit
  • Pregnancy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02813083

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United States, Minnesota
University of Minnesota Department of Medicine
Minneapolis, Minnesota, United States, 55455
Sponsors and Collaborators
University of Minnesota
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Principal Investigator: Daniel Mueller, M.D. University of Minnesota
Additional Information:

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Responsible Party: University of Minnesota Identifier: NCT02813083    
Other Study ID Numbers: 20494
First Posted: June 24, 2016    Key Record Dates
Last Update Posted: December 11, 2019
Last Verified: December 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Arthritis, Rheumatoid
Autoimmune Diseases
Joint Diseases
Musculoskeletal Diseases
Immune System Diseases
Rheumatic Diseases
Connective Tissue Diseases